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what might be collected if qualified staff at FDA or another organization were specifically charged with undertaking only monograph generation. For example, the timeline of this project required that industry and other stakeholders be given only a few weeks to a month to review the information included in the draft prototype monographs to determine if there was a need to volunteer data in their possession prior to the public meeting. In addition, the sources of information and the process for systematically collecting information were evaluated during this process and thus continually modified as subsequent monographs were developed. Thus the monographs, as well as the monograph summaries and the focused monographs in this volume, are considered prototypes and as such are not authoritative statements of the National Academies or the IOM on the safety of the specific dietary ingredients, but are put forward as examples of what might be done.

The six supplement ingredients selected to serve as the subjects of the prototype monographs were chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto, and shark cartilage. Development of the prototype monographs proved to be a useful tool to assess the practicality and ability of the Framework to guide a dietary supplement ingredient safety evaluation.

Criteria Used to Select Prototype Monograph Ingredients

The six ingredients were selected to fulfill several criteria and thus test the proposed framework from a variety of perspectives. One criterion, for example, was to review a variety of types of ingredients; thus the selection of ingredients for prototype monographs included at least one botanical, one well-characterized vitamin or mineral, one animal product, one hormonal product, and one “new” (post-October 1994) product. Another criterion was that the selected ingredients include substances for which a range in the types and quality of available information were anticipated. Finally, it was decided that selected ingredients should not be undergoing safety research by committee members. The range of ingredient types, available data sources, and resulting level of concern allowed the evaluation of various aspects of the proposed framework and provided an opportunity to improve the recommended approach.

Signal Detection

It is worth noting that the reasons substances were flagged initially as described in the proposed framework (the report previously released for comment) would have also brought them to FDA’s attention according to

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